Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 595 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Part I Dose Exploration | EXPERIMENTAL | Pre-specified nominal doses are proposed in the dose exploration. Intermediate doses may also be used if required based on the CRM design. |
| Part II Dose Expansion | EXPERIMENTAL | Dose selected from Part 1 dose exploration |
| Name | Type | Description |
|---|---|---|
| AMG 595 | DRUG | AMG 595 is an antibody drug conjugate that binds to EGFRvIII. |
Inclusion Criteria: * Karnofsky performance score \> or = 70% * Must have pathologically documented, and definitively diagnosed recurrent WHO Grade IV advanced malignant glioblastoma multiforme (Part 1 and Part 2) and/or WHO Grade III anaplastic astrocytoma (Part 1 only). * GBM and/or AA tumors exp...
AMG 595 is an investigational small molecule being developed for the treatment of advanced malignant glioma, a type of brain cancer. It is also being studied in conditions such as anaplastic astrocytomas and glioblastoma multiforme. The drug is currently in Phase 1 clinical development.
AMG 595 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting clinical research on this investigational oncology drug for advanced malignant glioma.
AMG 595 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for safety and tolerability in patients with advanced malignant glioma.
AMG 595 has one completed clinical trial registered as NCT01475006, titled "AMG 595 First-in-Human in Recurrent Gliomas." This Phase 1 study enrolled 32 participants with advanced malignant glioma, anaplastic astrocytomas, and glioblastoma multiforme, and was conducted in the United States and Australia.
Yes, the clinical trial for AMG 595, NCT01475006, was a controlled study. However, it was not randomized and was not double-blind. The trial enrolled adult patients aged 18 years and older with advanced malignant glioma and related brain tumor conditions.